Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The stated issue is discoloration, a cosmetic or quality defect, with no reported injuries or illnesses.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 5,689 units of GranuFlo Naturalyte Dry Acid Concentrate for Bicarbonate Dialysis. The product is indicated for the treatment of acute and chronic renal failure during hemodialysis. The recall was initiated because the concentrate may show discoloration.
The affected product is identified by Catalog Number OFD2225-3B and Lot Numbers 12NXGF011 and 12PXGF004. The recall covers units distributed nationwide in the United States.
Consumers and healthcare facilities should stop using the affected product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 5,689
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers:12NXGF011
- 12PXGF004
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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